Product code HQF
- Device name
- Laser, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.4390
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P990078S005 | HYPERION LTK SYSTEM | Sunrise Technologies, Inc. | 2002-05-08 |
| P990078S004 | SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK) | Sunrise Technologies, Inc. | 2001-03-16 |
| P990078S001 | HYPERION LTK SYSTEM | Sunrise Technologies, Inc. | 2000-12-11 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252979 | Voyager DSLT (430840610) | Belkin Vision, Ltd. | 2026-04-07 |
| K251507 | INTEGRE LIO | Quantel Medical | 2026-02-06 |
| K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | 2025-10-29 |
| K243014 | EyeQ nanoECP | Eyeq, Inc. | 2025-06-18 |
| K240615 | Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. | 2025-04-03 |
| K242397 | LYNX Photocoagulator | Norlase Aps | 2024-10-25 |
| K233911 | VISULAS combi | Carl Zeiss Meditec, AG | 2024-09-06 |
| K232417 | MR Q; MR Q SUPINE; MR Q SLT | Meridian AG | 2024-01-25 |
| K230722 | Eagle device | Belkin Vision, Ltd. | 2023-12-08 |
| K232051 | VISULAS green | Carl Zeiss Meditec | 2023-10-24 |
| K230350 | VISULAS yag | Carl Zeiss Meditec, Inc. | 2023-09-22 |
| K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | Meridian AG | 2023-09-12 |
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | Iridex Corporation | 2023-02-23 |
| K220974 | R:GEN | Lutronic Vision, Inc. | 2022-12-27 |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | Iridex Corporation | 2022-11-09 |
| K222395 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | Ellex Medical Pty, Ltd. | 2022-11-02 |
| K222157 | ECHO Photocoagulator | Norlase | 2022-10-11 |
| K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | Lumenis Be, Inc. | 2022-07-15 |
| K220430 | Capsulo | Quantel Medical | 2022-05-12 |
| K213592 | Iridex 810 Laser | Iridex Corporation | 2022-03-23 |
| K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | Ellex Medical Pty, Ltd. | 2021-12-16 |
| K203130 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2020-12-07 |
| K202760 | Iridex 810 Laser | Iridex Corporation | 2020-10-21 |
| K201623 | LION Photocoagulator | Norlase Aps | 2020-08-11 |
| K201502 | Vitra 810 | Quantel Medical | 2020-08-06 |
| K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2019-11-15 |
| K190448 | LightLas Pattern Scanning System - TruScan Pro | Light-Med(Usa), Inc. | 2019-05-24 |
| K190083 | Leaf Photocoagulator | Norlase Aps | 2019-05-03 |
| K181682 | VISULAS green | Carl Zeiss Meditec, AG | 2019-03-06 |
| K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | Topcon Medical Laser Systems, Inc. | 2018-05-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840096215304 | XLEND23MULTIFLEX | KATALYST SURGICAL LLC | 2025-06-24 |
| 10817489027391 | 23ga MultiFlex Laser Probe, Iridex Compatible | KATALYST SURGICAL LLC | 2018-11-26 |
| 00817489024218 | 23ga Endo-Ocular Probe-Straight, Iridex Compatible | KATALYST SURGICAL LLC | 2016-09-22 |
| 00817489024201 | 23ga Endo-Ocular Probe-Straight | KATALYST SURGICAL LLC | 2016-09-22 |
| 00817489024348 | 25ga Endo-Ocular Probe- Flexible Curved, Quantel Compatible | KATALYST SURGICAL LLC | 2016-09-22 |
| 00817489024331 | 25ga Endo-Ocular Probe- Flexible Curved, Iridex Compatible | KATALYST SURGICAL LLC | 2016-09-22 |
| 00817489024324 | 25ga Endo-Ocular Probe- Flexible Curved | KATALYST SURGICAL LLC | 2016-09-22 |
| 00817489024300 | 23ga Endo-Ocular Probe- Flexible Curved, Quantel Compatible | KATALYST SURGICAL LLC | 2016-09-22 |
| 00817489024294 | 23ga Endo-Ocular Probe- Flexible Curved, Iridex Compatible | KATALYST SURGICAL LLC | 2016-09-22 |
| 00817489024287 | 23ga Endo-Ocular Probe- Flexible Curved | KATALYST SURGICAL LLC | 2016-09-22 |
| 00817489024263 | 25ga Endo-Ocular Probe-Straight, Alcon Compatible | KATALYST SURGICAL LLC | 2016-09-22 |
| 00817489024256 | 25ga Endo-Ocular Probe-Straight, Iridex Compatible | KATALYST SURGICAL LLC | 2016-09-22 |
| 00817489024249 | 25ga Endo-Ocular Probe-Straight | KATALYST SURGICAL LLC | 2016-09-22 |
| 00817489024225 | 23ga Endo-Ocular Probe-Straight, Alcon Compatible | KATALYST SURGICAL LLC | 2016-09-22 |
| 00817489020203 | 23ga Tapered Flexible Curved Laser Probe, Iridex | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020197 | 27ga Straight Laser Probe, DORC | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020180 | 27ga Straight Laser Probe, Nidek Thread | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020173 | 27ga Straight Laser Probe, Quantel | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020166 | 27ga Straight Laser Probe, Alcon | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020159 | 27ga Straight Laser Probe, Iridex | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020142 | 25ga Straight Laser Probe, DORC | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020135 | 25ga Straight Laser Probe, Nidek Thread | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020128 | 25ga Straight Laser Probe, Quantel | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020111 | 25ga Straight Laser Probe, Alcon | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020104 | 25ga Straight Laser Probe, Iridex | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020098 | 23ga Straight Laser Probe, DORC | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020081 | 23ga Straight Laser Probe, Nidek Thread | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020074 | 23ga Straight Laser Probe, Quantel | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020067 | 23ga Straight Laser Probe, Alcon | KATALYST SURGICAL LLC | 2016-08-04 |
| 00817489020050 | 23ga Straight Laser Probe, Iridex | KATALYST SURGICAL LLC | 2016-08-04 |